Director, Engineering, Validation and Maintenance (EVM)

Summary of Role

The Director, Egineering, Validation and Maintenance (EVM) is accountable for driving results in a fast-paced environment by developing and executing engineering, validation and maintenance strategies supporting on-going and future facility, utility, manufacturing and laboratory systems throughout the life cycle of an asset. The Director of EVM directly manages and is reponsible for all staff involved in facilities, maintenance, project engineering, project validation, and calibration activities for the site. Engineering includes but is not limited to project scope, cost estimates, schedules, design, procurement, and installation/construction. Validation includes but is not limited to factory acceptance tests, commissioning, installation qualification, operational qualification, performance qualification, and re-qualification program. Maintenance includes but is not limited to preventative maintenance, work order repairs, metrology, and facilities programs including security, housekeeping, landscaping and pest control. In addition, the Director, Engineering, Validation and Maintenance supports the strategic development of the organizational capabilities of the department. The position requires execution of the Sterling Values and non-negotiables, as well as expertise in functional competencies included in this position profile. This role provides strategic leadership for the site master plan, ensuring alignment with business growth, operational requirements, and long-term infrastructure needs. The Director is responsible for translating User Requirement Specifications (URS) from operations into scalable, compliant, and efficient engineering solutions.

Essential Functions

• Develops, implements, and maintains robust engineering, validation and maintenance standards.
• Manages internal engineering, validation and maintenance teams and processes as well as provides support to other groups including manfacturing and lab operations.
• Oversees the equipment, facilities and utilities qualification program and drives innovation to remain current.
• Leads the design, implementation, monitoring and control and closure stages of major department and capital projects for the facility.
• Develops, governs, and continuously updates the site engineering master plan, aligning infrastructure, capacity, and utilities with long-term business and operational strategy.
• Leads cross-functional collaboration with operations, quality, and technical teams to translate User Requirement Specifications (URS) into robust, compliant, and cost-effective engineering designs and solutions.
• Owns the integration of capital projects and asset strategies into the broader site master plan and infrastructure roadmap.
• Leads and actively participates in client interface in regards to equipment, facility and utility lifecycle.
• Oversees and develops the facility annual and long-term capital investment plan and departmental operating budget.
• Cultivates an efficient, professional and safe working atmosphere and ensures timely results are achieved.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Lead the Germantown Engineering, Validation, and Maintenance organization, providing strategic direction and day-to-day leadership for managers and site teams, including 5 direct and 15+ indirect reports.
• Build and develop a high-performing team through effective hiring, coaching, performance management, succession planning, and employee development.
• Set priorities, allocate resources, and ensure timely execution of departmental objectives in support of site operations and business goals.
• Foster a culture of safety, accountability, collaboration, and continuous improvement across the organization.
• Ensure compliance with cGMP, safety, and company training requirements, maintaining organizational readiness and capability.
• Partner cross-functionally with Operations, Quality, Technical, and Site Leadership to align Engineering, Validation, and Maintenance strategies with current and future site needs.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this position.

Key Competencies

• Expert knowledge in cGMP, engineering standards, methodologies and maintenance, project engineering, and validation lifecycle required.
• Knowledge of quality systems preferred.
• Excellent verbal and written communication, presentation skills, project management, organizational skills detail orientation and business acumen required.
• Excellent experience with customer interface and preferred cross-functional and international business experience preferred.
• Proficient in Microsoft Office applications.
• Duties, responsibilities, and activities may change at any time with or without notice.

Education and Experience

• Bachelor's degree in Engineering, Chemical, Mechanical, Biochemical, or equivalent required.
• 5-8 years of related experience required; 12+ years preferred.

Certifications, Business Licenses, Registrations

• None.

Travel Requirement

• Up to 5% travel required.

Other Qualifications, Skills and Abilities

• This position is eligible for a flexible schedule.
• This position is not eligible for remote / hybrid work location.

Physical Demands and Work Environment

The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to sit. The employee is occasionally required to stand; walk and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level is moderate to noisy. Occasionally, employee may be exposed to airborne particles and fumes. Occasionally, employee may be exposed to chemicals. Must have the ability to wear PPE as required. Employee occasionally may be exposed to moving mechanical parts and vibration.

Diversity and Inclusion

Sterling values diversity and we are committed to creating an inclusive environment for all employees. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion, sex, pregnancy, age, national origin, physical or mental disability, past or present military service, marital status, gender identification or expression, medical condition (including genetic characteristics) or any other protected characteristic as established by law.

Why Consider Sterling?

Sterling Pharma Solutions is a global contract development and manufacturing organisation (CDMO) with more than 50 years' experience in developing and manufacturing Active Pharmaceutical Ingredients (APIs). This is complimented by Antibody Drug Conjugate (ADC) research and development bioconjugation services.

We are a fast growing, dynamic business with facilities in the UK and the US, where we employ more than 800 talented and passionate people who support our customers in bringing new medicines to market, improving and saving the lives of patients.

Our culture and our way of working is what really sets us apart as a business; we aim to deliver an exceptional experience to our customers and our employees. You can expect to be part of a supportive team, all working towards a shared goal: to deliver first-class science and service to our customers every day.